CAP/CTM HCV TEST, V2.0

Additional Manufacturer Narrative

THE INVESTIGATION INTO THE CASE ISSUE IS CURRENTLY ON-GOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED AT THE END OF THE INVESTIGATION. THE COMMON DEVICE NAME IN THE MDR FORM WAS TRUNCATED DUE TO CHARACTER LIMITATIONS. THE COMMON DEVICE NAME FOR THIS DEVICE IS "ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF (B)(6)". (B)(4).

Description of Event or Problem

A CUSTOMER FROM THE UNITED STATES REPORTED THE GENERATION OF OVER-QUANTITATED (B)(6) RESULTS FOR 3 PATIENTS ((B)(6)) WHEN TESTED WITH THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST, V2.0 (LOT W14484). THE OVER-QUANTITATED RESULTS WERE (B)(6). IT WAS INDICATED THAT THE AMPLIFICATION CURVES GENERATED FOR THE (B)(6) RESULTS DID NOT PRESENT WHAT WOULD APPEAR TO BE A HIGH TITER SAMPLE. UPON REPEAT TESTING WITH THE SAME LOT (W14484), TARGET NOT DETECTED (TND) OR (B)(6) RESULTS WERE GENERATED. NO HARM WAS INDICATED THROUGH THE CASE. THIS MDR REPORT WILL FOCUS ON SAMPLE ID (B)(6). SEPARATE MDR REPORTS WILL BE SUBMITTED FOR SAMPLE IDS (B)(6).

Additional Manufacturer Narrative

A CUSTOMER FROM THE UNITED STATES REPORTED THE GENERATION OF (B)(6) RESULTS FOR A PATIENT (SAMPLE (B)(6)) WHEN TESTED WITH THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (LOT W14484). THE (B)(6) RESULT WAS > (B)(6). IT WAS INDICATED THAT THE AMPLIFICATION CURVE GENERATED FOR THE (B)(6) RESULT DID NOT PRESENT WHAT WOULD APPEAR TO BE A HIGH TITER SAMPLE. AS SUCH, REPEAT TESTING WAS ORDERED. UPON REPEAT TESTING WITH THE SAME LOT (W14484), A (B)(6) RESULT WAS GENERATED. NO HARM WAS INDICATED THROUGH THE CASE. A (B)(6) RESULT WHEN THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 IS USED FOR DIAGNOSIS OR MONITORING MAY RESULT IN PSYCHOLOGICAL DISTRESS. HOWEVER, PATIENTS TREATED FOR (B)(6) ARE FOLLOWED IN SPECIALIZED CLINICS WHERE (B)(6) WOULD BE IDENTIFIED AS SUCH AFTER ADDITIONAL LABORATORY TESTS. THE AMERICAN ASSOCIATION FOR THE STUDY FOR THE STUDY OF LIVER DISEASES (AASLD) GUIDELINES RECOMMEND (B)(6) GENOTYPING FOR PATIENTS WITH (B)(6) RESULTS AND RECOMMEND RESISTANCE ASSOCIATED VARIANT TESTING IN CERTAIN CIRCUMSTANCES. THIS ADDITIONAL TESTING WOULD YIELD (B)(6) RESULTS; THEREBY, POINTING TOWARDS A (B)(6) TEST RESULT. A MIS-DIAGNOSIS OF (B)(6) IN A PATIENT WITH (B)(6) LIVER DISEASE IS UNLIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES SINCE EVALUATION OF PATIENTS WITH LIVER DISEASE IS BASED ON CLINICAL PRESENTATION AND MULTIPLE TEST RESULTS BUT NOT EXCLUSIVELY ON THE (B)(6) RESULT. WHILE HEALTH HAZARDS OF (B)(6) RESULTS MAY RANGE FROM PSYCHOLOGICAL DISTRESS TO ERRONEOUS INITIATION OF (B)(6) TREATMENT WITH POTENTIAL ADVERSE EVENTS IT IS UNLIKELY THAT THESE OCCUR. ADVERSE EVENTS OF NEW (B)(6) REGIMENS ARE LESS COMMON AND MOST IMPORTANTLY THE INITIATION OF TREATMENT IS NOT BASED EXCLUSIVELY ON THE RESULT OF A (B)(6) TEST. THROUGH THE COURSE OF THE INVESTIGATION, NO CLEAR ROOT CAUSE HAS BEEN IDENTIFIED, AND CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED, AS APPROPRIATE. (B)(6).